Details for New Drug Application (NDA): 090228
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NDA 090228 describes FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma, Avet Lifesciences, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, and Teva, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 090228
| Tradename: | FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | fosinopril sodium; hydrochlorothiazide |
| Patents: | 0 |
Pharmacology for NDA: 090228
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 090228
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | fosinopril sodium; hydrochlorothiazide | TABLET;ORAL | 090228 | ANDA | CIPLA USA INC. | 69097-972 | 69097-972-07 | 100 TABLET in 1 BOTTLE (69097-972-07) |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE | fosinopril sodium; hydrochlorothiazide | TABLET;ORAL | 090228 | ANDA | CIPLA USA INC. | 69097-973 | 69097-973-07 | 100 TABLET in 1 BOTTLE (69097-973-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;12.5MG | ||||
| Approval Date: | Jul 9, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG;12.5MG | ||||
| Approval Date: | Jul 9, 2009 | TE: | AB | RLD: | No | ||||
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